lung cancer
Conditions
Interventions
Experimental group:Carilizumab (200mg ) in combination with carboplatin two-agent chemotherapy + thalidomide 100mg qd orally, 21 days a cycle, 4-6 cycles
Control group:Carilizumab (200 mg ) in combination with carboplatin two-agent chemotherapy, 21-day cycle, 4-6 cycles
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients were =18 years old at the time of signing the informed consent form, both male and female. 2. Patients with histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) and stage IIIB/IV tumors (as determined by the International Association for the Study of Lung Cancer (IASLC) Manual of Thoracic Tumor Staging, 8th edition). 3. Patients have not received prior systemic systemic chemotherapy for advanced/metastatic NSCLC. The use of chemotherapy and/or radiotherapy as part of neoadjuvant/adjuvant therapy is permitted as long as treatment has been completed for at least 12 months prior to the diagnosis of advanced or metastatic disease. 4. ECOG PS score: 0-1. 5. expected survival = 3 months. 6. all screening phase laboratory tests are performed according to protocol requirements and the values of laboratory tests performed at screening must meet the following criteria: 1) Routine blood tests: (no blood transfusion, G-CSF, or drug correction within 14 days prior to screening) a) Hemoglobin (HB) = 90 g/L; b) Absolute neutrophil count (ANC) = 1.5 x 109/L; c) Platelet count (PLT) = 100 × 109/L; d) White blood cell count (WBC) =4.0×109/L and =15×109/L; 2) Biochemical tests: (no blood or albumin transfusion within 14 days prior to screening) e) AST and ALT = 1.5 ULN (= 5 ULN if tumor liver metastases are present); f) ALP = 2.5 ULN; g) TBiL = 1.5 ULN; h)ALB=30 g/L; i)Cr =1.5 ULN along with creatinine clearance (CrCL) =60 mL/min (Cockcroft-Gault formula); j) APTT = 1.5 ULN with concomitant INR or PT = 1.5 ULN (not receiving anticoagulation). 7. ability to swallow tablets normally.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other pathohistologic types, including mixed squamous adenocarcinoma, and NSCLC with small cell lung cancer component. 2. Patients with known EGFR mutations or ALK positivity. 3. Patients with prior treatment with PD-(L)1, CTLA-4. 4. Patients with active central nervous system (CNS) metastases, active autoimmune disease, diabetic patients, hypothyroidism, etc. 5. Patients with immune deficiencies such as human immunodeficiency virus (HIV) infection, poorly controlled infectious diseases such as active viral hepatitis B or active tuberculosis, interstitial pneumonitis, severe cardiac, hepatic, and renal diseases, coagulation disorders, psychiatric disorders, or patients with other tumor combinations 6. Serious infections (CTCAE > grade 2), infectious complications requiring treatment, bacteremia, severe pneumonia, etc. occurred within 4 weeks before enrollment; 7. Major surgery (excluding diagnostic surgery) within 4 weeks prior to enrollment or scheduled to undergo major surgery during the study period 8.Alcohol dependent or patients with a history of drug or substance abuse within the last 1 year; 9. Women who are pregnant or breastfeeding. 10. Known allergy to the study drug or excipients. 11.Have been treated with any other experimental drug or participated in another interventional clinical study within 4 weeks prior to signing the ICF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reactive cutaneous capillary endothelial proliferation,RCCEP;ORR,PFS,OS,DCR,DoR; | — |
Secondary
| Measure | Time frame |
|---|---|
| EOETC QLQ-C30 & QOL-LC-13; | — |
Countries
China
Contacts
Public ContactZuo Zhitong
Affiliated Hospital of Jiangnan University
Outcome results
None listed